19According to the principles laid down in Directive 65/65, no medicinal product may be placed on the market for the first time in a Member State unless a marketing authorisation has been issued in accordance with the directive by the competent authority of that State. Applications for marketing authorisations for a medicinal product submitted by the person responsible for placing it on the market must contain the information and be accompanied by the documents listed in Article 4 of the directive, even where the medicinal product concerned is already the subject of an authorisation issued by the competent authority of another Member State (Case C-94/98 Rhône-Poulenc Rorer and May & Baker [1999] ECR I-8789, paragraph 23).
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